Department of Health and Human Services September 9, 2005 – Federal Register Recent Federal Regulation Documents

The Indian Health Service (IHS) announces the award of a cooperative agreement that will be funded on a competitive continuing basis to the National Native American Emergency Medical Services Association (NNAEMSA) for a demonstration project to improve emergency medical services for Native American people by improving communications between the IHS and the Native American Emergency Medical Services (EMS) providers; by improving communications and information among other federal agencies, professional organizations and Native American EMS providers; and by supporting an Annual Educational Conference. Project Period: The cooperative agreement is for a five-year project period effective on or about September 15, 2005 to September 14, 2010. Amount of Award(s): Total funding for the project is $450,000. Funding in the amount of $90,000.00 is available in FY 2005. Continuation awards within an approved project period will be made on the basis of satisfactory progress as evidenced by required reports and the availability of funds.

NICEATM announces a second meeting of an expert panel by teleconference on September 19, 2005, to evaluate (1) revised accuracy and reliability analyses of four in vitro test methods proposed for detecting ocular corrosives and severe irritants and (2) a revised list of proposed reference substances for validation studies on in vitro test methods for identifying ocular corrosives and severe irritants. The four in vitro test methods under consideration are the (1) Bovine Corneal Opacity and Permeability (BCOP) assay, (2) Hen's Egg Test Chorion Allantoic Membrane (HET-CAM), (3) Isolated Rabbit Eye (IRE) assay, and (4) Isolated Chicken Eye (ICE) assay. The revised analyses and revised list of proposed reference substances are available in an addendum to the draft Background Review Documents (BRDs) for the four methods (available at https://iccvam.niehs.nih.gov/methods/ocudocs/ reanalysis.htm). A previous Federal Register notice solicited public comment on the revised analyses and revised list of proposed reference substances (Vol. 70, No. 142, pg. 43149, July 26, 2005). Comments submitted in response to the July 26, 2005 Federal Register notice will be considered at the expert panel meeting and do not need to be resubmitted. The public is invited to attend the teleconference and will be provided with an opportunity to make oral comments during the public comment period. Interested individuals can attend the meeting via a phone line or in person at the NIEHS campus (see ADDRESSES below). Participation is limited only by the number of phone lines available and by the number of available seats at the teleconference site. Additional meeting information may be obtained on the ICCVAM/ NICEATM Web site (https://iccvam.niehs.nih.gov) or by contacting NICEATM (see ADDRESSES below).

In accordance with the requirements of the Privacy Act of 1974, we are proposing to create a new SOR titled, ``Data Collection Secondary to Coverage Decision (DCSCD) System, HHS/CMS/OCSQ, System No. 09-70-0547.'' National Coverage Determinations (NCDs) are determinations by the Secretary with respect to whether or not a particular item or service is covered nationally under title XVIII of the Social Security Act (the Act) Sec. 1869(f)(1)(B). In order to be covered by Medicare, an item or service must fall within one or more benefit categories contained within Part A or Part B, and must not be otherwise excluded from coverage. Moreover, with limited exceptions, the expenses incurred for items or services must be ``reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member,'' Sec. 1862(a)(1)(A). CMS has determined that the evidence is adequate to conclude that certain identified diagnoses are reasonable and necessary in several patient groups where certain criteria for these patients have been met. The reasonable and necessary determination requires that patients meet the criteria and are consistent with the trials discussed. Collection of these data elements allows that determination to be made. We are particularly interested in seeing evidence that would permit us to make a coverage or non-coverage decision, i.e., to move a diagnostic indication from coverage under a clinical trial or study to coverage or non-coverage based on definitive evidence of benefit, no benefit, or harm. If adequate new evidence is available, the decision may be changed to either ``coverage based on evidence of benefit,'' ``limited coverage'' or ``non-coverage based on evidence of harm or no benefit.'' The purpose of this system is to collect and maintain data on patients to review determinations of ``reasonable and necessary'' with respect to whether or not a particular item or service is covered nationally under title XVIII of the Act Sec. 1869(f)(1)(B). Information retrieved from this system will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor or consultant; (2) assist another Federal or state agency with information to enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) to an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects; (4) support constituent requests made to a congressional representative; (5) support litigation involving the agency; and (6) combat fraud and abuse in certain health benefits programs. We have provided background information about the new system in the SUPPLEMENTARY INFORMATION section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See EFFECTIVE DATES section for comment period.